Symbicort® Turbuhaler® now approved by Health Canada for use in mild persistent, moderate, or severe asthma

MISSISSAUGA, ON, Sept. 30, 2019 /CNW/ - AstraZeneca Canada announced today that Health Canada has approved the expanded use of Symbicort^® Turbuhaler^® (budesonide/formoterol) for the treatment of mild persistent asthma in patients 12 years and older. Symbicort Turbuhaler is now approved as an anti-inflammatory reliever in Canada for use in mild persistent, moderate, or severe asthma patients.¹  

The approval was based on positive results from the Phase III SYGMA 1 and 2 trials, published in the New England Journal of Medicine,^2,3 which evaluated the efficacy of Symbicort Turbuhaler taken only as-needed as an anti-inflammatory reliever versus current standard of care therapies in mild asthma:

• As an alternative to current reliever therapy, short acting beta-2 agonist (SABA) also taken as-needed.
• As an alternative to regular maintenance controller therapy (twice-daily budesonide, an inhaled corticosteroid, ICS) plus SABA as-needed.

"Health Canada's approval supports the use of Symbicort Turbuhaler as an anti-inflammatory reliever as-needed for patients with mild persistent asthma to treat inflammation, not just asthma symptoms," said Dr. Neil Maresky, Vice President, Scientific Affairs, AstraZeneca Canada. "It builds on the established clinical profile of the medicine as an as-needed anti-inflammatory reliever plus maintenance in moderate-to-severe disease."

The Global Initiative for Asthma (GINA), in its recent 2019 update of the Global Strategy for Asthma Management and Prevention, recommends the use of low dose budesonide-formoterol combination therapy as-needed as the preferred reliever therapy across all asthma severities. 

"It's estimated more than 3.8 million people in Canada live with asthma, which continues to have a profound impact on patients' lives," said Dr. Paul M. O'Byrne, Dean and Vice-President of the Faculty of Health Sciences at McMaster University and the International Coordinating Investigator for SYGMA 1. "Evidence shows that we can reduce that impact by treating the underlying inflammation, in addition to managing symptoms. This new approval of Symbicort Turbuhaler for use in mild persistent asthma means that Canadian clinicians will now be able to offer this anti-inflammatory reliever therapy to their patients, providing symptom relief and addressing the underlying inflammation at the same time."

"We should have zero tolerance for asthma attacks in Canada," said Vanessa Foran, President and CEO of Asthma Canada. "People living with asthma are at risk for an asthma attack whether they have mild, moderate or severe asthma. It is encouraging that use of an anti-inflammatory reliever has been approved for use across the spectrum of severity, which addresses not just symptoms, but also the underlying inflammation."

Safety and tolerability data from the SYGMA trials in mild asthma patients for Symbicort Turbuhaler as-needed were consistent with the known profile of the medicine. The most commonly reported adverse events were upper respiratory tract infection (URTI), viral URTI, asthma, pharyngitis, bronchitis, headache, and allergic rhinitis.^2,4

About Symbicort Turbuhaler
Symbicort Turbuhaler is a combination formulation containing budesonide, an inhaled corticosteroid (ICS) that treats underlying inflammation, and formoterol, a long-acting beta2-agonist bronchodilator (LABA) with a fast onset of action, in a single inhaler. Symbicort Turbuhaler is now approved for use as different treatment approaches for patients with mild persistent, moderate, or severe asthma. Symbicort Turbuhaler was launched in 2000 and is approved in approximately 120 countries to treat asthma and/or COPD.

About Asthma
Asthma is the third-most common chronic disease in Canada,⁵ and it affects more than 3.8 million Canadians.⁶ Asthma symptoms typically include coughing, wheezing, shortness of breath, and chest tightness. With increased airway inflammation, the lining of the airways become irritated and swollen, leading to an exacerbation of symptoms.⁷

All asthma patients are at risk of severe attacks, regardless of their disease severity, adherence to treatment or level of control.^8-11 There are an estimated 176 million asthma exacerbations globally per year; these exacerbations may be physically threatening and emotionally significant for many patients.¹² However, despite the fact that asthma is a chronic, variable inflammatory disease, patients are either under-prescribed or under-use their anti-inflammatory 'preventer' therapy and over-rely on their SABA reliever, which can mask symptom worsening.^13-16 Taking a SABA inhaler alone during or after a worsening of symptoms does not address the underlying inflammation¹³, leaving patients at risk of asthma exacerbation and potential exposure to frequent bursts of oral corticosteroids.¹⁷

Apart from direct costs related to healthcare for asthma patients (such as medications and visits to the doctor), there are indirect costs owing to lost productivity. The cost of asthma to the Canadian economy is expected to climb to $4.2 billion annually by 2030.¹⁸

About AstraZeneca in respiratory diseases
Respiratory is one of AstraZeneca's main therapy areas, and our medicines reached more than 18 million patients as maintenance therapy in 2018. AstraZeneca's aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification.

About AstraZeneca Canada
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular, Renal and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 850 employees across the country and our AstraZeneca Canada headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca.

* Corresponds to a delivered dose of budesonide/formoterol of 160/4.5 µg
† Corresponds to a 0.4 mg delivered dose of terbutaline, delivered by a Turbuhaler
‡ Severe exacerbations defined as worsening asthma requiring use of systemic corticosteroids for ≥3 days, inpatient hospitalisation, or emergency department visit requiring systemic corticosteroids

REFERENCES:
1.	AstraZeneca Canada Inc., Symbicort^® Turbuhaler^® (budesonide/formoterol) Product Monograph. Accessed September, 2019, available at: https://www.astrazeneca.ca/en/our-medicines.html
2.	O'Byrne PM, FitzGerald JM, Bateman ED, et al. Inhaled combined budesonide-formoterol as needed in mild asthma. N Engl J Med. 2018; 378: 1865-1876.
3.	Bateman ED, Reddel HK, O'Byrne PM, et al. As-needed budesonide-formoterol versus maintenance budesonide in mild asthma. N Engl J Med. 2018; 378: 1877-1887.
4.	O'Byrne PM, FitzGerald JM, Bateman ED, et al. Inhaled combined budesonide-formoterol as needed in mild asthma. Supplementary Appendix. N Engl J Med. 2018; 378: 1865-1876.
5.	Statistics Canada, Catalogue no.82-625-X. Health Fact Sheets, Chronic Conditions, 2016. September 2017. https://www150.statcan.gc.ca/n1/pub/82-625-x/2017001/article/54858-eng.htm
6.	Public Health Agency of Canada. Report from the Canadian Chronic Disease Surveillance System: Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Canada, 2018.
7.	Asthma Canada, Asthma Facts and Statistics, 2019. https://asthma.ca/wp-content/uploads/2019/02/Asthma-101.pdf Accessed August 2019.
8.	Olaguibel JM, Quirce S, Julia B, et al. Measurement of asthma control according to Global Initiative for Asthma guidelines: a comparison with the Asthma Control Questionnaire. Respir Res. 2012; 13: 50.
9.	Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009.
10.	Bateman ED, Hurd SS, Barnes PJ, et al. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008; 31: 143–78.
11.	Sastre J, Fabbri LM, Price D, et al. Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J. 2016; 9: 13.
12.	AstraZeneca Pharmaceuticals. Data on file. Budesonide/formoterol: Annual Rate of Exacerbations Globally (ID:SD-3010-ALL-0017).
13.	Humbert M, Andersson TL, Buhl R. Budesonide/formoterol for maintenance and reliever therapy in the management of moderate to severe asthma. Allergy. 2008; 63: 1567–80.
14.	Rabe KF, Vermeire PA, Soriano JB, Maier WC. Clinical management of asthma in 1999: the asthma insights and reality in Europe (AIRE) study. Eur Respir J. 2000; 16: 802–7.
15.	Tattersfield AE, Postma DS, Barnes PJ, et al. on behalf of the FACET International Study Group. Exacerbations of asthma: a descriptive study of 425 severe exacerbations. Am J Respir Crit Care Med. 1999; 160: 594–9.
16.	Adams RJ, Fuhlbrigge A, Guilbert T, et al. Inadequate use of asthma medication in the United States: results of the asthma in America national population survey. J Allergy Clin Immunol. 2002; 110: 58–64.
17.	Price DB, Trudo F, Voorham J, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018; 11: 193–204.
18.	Cost Risk Analysis for Chronic Lung Disease in Canada, The Conference Board of Canada, Louis Theriault, Gregory Hermus, Danielle Goldfarb, Carole Stonebridge, Fares Bounajm, March 15 2012 http://www.conferenceboard.ca/elibrary/abstract.aspx?did=4585

SOURCE AstraZeneca

Mary-Anne Cedrone, AstraZeneca Canada, E-mail: [email protected]; Emily Williams, Hill+Knowlton Strategies, Tel: [phone], E-mail: [email protected]